Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influe… (NCT06279871) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults
Australia, Costa Rica, Honduras1,514 participantsStarted 2024-03-27
Plain-language summary
This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Individuals with acute medical illness or febrile illness.
. Individuals with a positive SARS-CoV-2 rapid antigen test at Screening.
. Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection within the past 5 months or history of COVID-19 with ongoing sequelae.
. Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any components of mRNA vaccine, or influenza vaccine, including egg protein.
. Individuals who have a positive pregnancy test at the Screening visit or who intend to become pregnant or breastfeed during the study.
. Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 3 trial studying a self-amplifying mRNA COVID-19 vaccine given alongside flu vaccines — how does that combination approach compare to getting each vaccine separately, and is that something worth considering for my own situation?
2The trial measured neutralizing antibody levels against the Omicron XBB.1.5 subvariant at 29 days — given that newer variants have emerged since then, how relevant do you think those antibody results are to the COVID strains circulating now?
3Since the trial is already completed, have the full results been published or reviewed, and do you know whether the self-amplifying mRNA vaccine showed immune responses comparable to standard COVID-19 boosters?
4The study looked at immune responses to both COVID-19 and influenza at the same time — if I need both vaccines, does the evidence from a trial like this suggest it's safe and effective for me to get them together rather than separately?
5Self-amplifying mRNA is a newer vaccine technology — based on what this trial found about safety, are there any side effects or risks I should be aware of that might be different from the standard mRNA vaccines I've already received?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Groups 2a and 2b and ARCT-154-J01 Historical Control: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody Titers Against Omicron XBB.1.5 Subvariant at Day 29
Timeframe: Day 29
2
Groups 2a and 2b and ARCT-154-J01 Historical Control: Number of Participants With Seroconversion to SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29
Timeframe: Day 29
3
Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29
Timeframe: Day 29
4
Groups 1a and 2a: Adjusted GMTs of SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29